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Terminated

Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.

FDA Recall Z-1670-2010 · Posted 2010-05-26

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2010-03-10
Date Terminated2010-10-18
Product Quantity5

Reason for Recall

The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.

Firm Action

Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031693MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HABiomet, Inc. · 2003-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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